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GMP UNIVERSITY – INTERNAL AUDITS AND FDA INSPECTIONS

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Make Key Decisions Based on an Effectively Managing Risks in Your Quality System

August 19 - August 21

San Francisco, United States



Are Your Quality Systems Inspection Ever-Ready?

Internal Audits are an integral part of FDA inspection readiness and should ensure your Quality Systems hold water under regulatory scrutiny. This event takes a deep dive into building an internal audit program that leaves critical elements in your QS are ever-ready for any regulatory official looking at your organization under a microscope. This conference takes participants through a journey of building the A-tea and implementing a best-in-class procedures that impress FDA investigators.

35 Tutorials Addressing Today’s Top Challenges

Internal Audits and FDA Inspections

  • Interpret and Respond to Regulatory Concerns
  • Dive into Hot Topics for Regulatory Inspections – Data Integrity, Metrics and QRM
  • Attend a Bio/Pharmaceutical Audit Management Boot Camp
  • See a Medical Device Single Audit Process (MDSAP) Manufacturer Case Study
  • Inspection Readiness – What It Mean and How Can You Achieve It
  • Create a “Communication with Inspectors” Playbook
  • Discover Documentation Practices and Superior Quality Management Software
  • Learn How to Use Risk-Based Auditing to Your Advantage
  • Build a Sustainable and Effective Internal Audit Program, Boost Compliance and Increase Value to the Organization
  • Implement Quality Metrics and Quality Culture Programs

 

 

Build and Manage Quality Systems Programs that are Inspection Ever-Ready

  • Validation/Qualification (lifecycle management)
  • Quality Risk Management (QRM)
  • Contamination Control
  • Internal Audit Programs
  • Data Integrity
  • Training/Qualification of Personnel
  • Deviation Management
  • Corrective and Preventive Actions (CAPA)
  • Complaint Management
  • Change Control

 

Personnel in the Following Environments Should Attend:

  • Auditors
  • QA/QC
  • Validation
  • Manufacturing
  • Laboratory Management
  • Regulatory Affairs
  • Quality Systems Management

 

This event is also appropriate to business development and sales managers that offer innovative solutions for quality systems management, document management systems; and solution providers for validation/quality departments.

 

Send Your Team! This Event is Co-located with:

CHANGE CONTROL

QUALITY RISK MANAGEMENT

Agenda

More Information To Follow Soon

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Details

Start:
August 19
End:
August 21
Event Category:

Venue

San Francisco, CA
San Francisco, CA United States

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